Trial Outcomes & Findings for An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis (NCT NCT03943147)
NCT ID: NCT03943147
Last Updated: 2022-10-17
Results Overview
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From baseline up to 52 weeks after first dose in Part B
Results posted on
2022-10-17
Participant Flow
Participants with an inadequate renal response to MMF may be randomized to blinded study treatment BMS-986165 3 mg BID, BMS-986165 6 mg BID, or placebo BID, as add-on therapy to MMF in Part B. No participants were randomized to receive BMS-986165 3 mg BID or placebo BID due to low enrollment.
Participant milestones
| Measure |
Open Label MMF
All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks.
Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.
The following suggested target doses of MMF should be reached by the time of randomization:
* 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent
* 3.0 g/day for participants self-described as Black, African American, or of African descent
* 2.0 g/day for all others
|
Open Label MMF + BMS-986165
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|---|
|
Open-Label MMF Run-in (Part A)
STARTED
|
16
|
0
|
|
Open-Label MMF Run-in (Part A)
COMPLETED
|
6
|
0
|
|
Open-Label MMF Run-in (Part A)
NOT COMPLETED
|
10
|
0
|
|
Blinded Treatment (Part B)
STARTED
|
5
|
1
|
|
Blinded Treatment (Part B)
COMPLETED
|
2
|
1
|
|
Blinded Treatment (Part B)
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Open Label MMF
All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks.
Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.
The following suggested target doses of MMF should be reached by the time of randomization:
* 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent
* 3.0 g/day for participants self-described as Black, African American, or of African descent
* 2.0 g/day for all others
|
Open Label MMF + BMS-986165
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|---|
|
Open-Label MMF Run-in (Part A)
Other reasons
|
4
|
0
|
|
Open-Label MMF Run-in (Part A)
Adverse Event
|
1
|
0
|
|
Open-Label MMF Run-in (Part A)
Non-compliance with study drug
|
1
|
0
|
|
Open-Label MMF Run-in (Part A)
Protocol-specified withdrawal criterion met
|
1
|
0
|
|
Open-Label MMF Run-in (Part A)
Study terminated by sponsor
|
3
|
0
|
|
Blinded Treatment (Part B)
Study terminated by sponsor
|
3
|
0
|
Baseline Characteristics
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
Baseline characteristics by cohort
| Measure |
Open Label MMF
n=15 Participants
All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks.
Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.
The following suggested target doses of MMF should be reached by the time of randomization:
* 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent
* 3.0 g/day for participants self-described as Black, African American, or of African descent
* 2.0 g/day for all others
|
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 52 weeks after first dose in Part BPopulation: All randomized participants in Part B
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
|
1 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 52 weeks after first dose in Part BPopulation: All randomized participants in Part B
The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline up to 52 weeks after first dose in Part BPopulation: All randomized participants in Part B
The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Diastolic Blood Pressure(mmHg)
|
-3.45 Percent change from baseline
|
|
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Systolic Blood Pressure(mmHg
|
5.22 Percent change from baseline
|
|
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Heart Rate(beats/min)
|
16.87 Percent change from baseline
|
|
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Respiratory Rate(breaths/min)
|
6.25 Percent change from baseline
|
|
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Temperature(C)
|
-1.35 Percent change from baseline
|
PRIMARY outcome
Timeframe: From baseline up to 52 weeks after first dose in Part BPopulation: All randomized participants in Part B
The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: All randomized participants in Part B
The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)
|
-34.86 Percent change from baseline
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants in Part B
The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants in Part B
The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants in Part B
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants in Part B
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants in Part B
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants in Part B
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
Outcome measures
| Measure |
Open Label MMF + BMS-986165
n=1 Participants
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|
|
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)
|
0 Participants
|
Adverse Events
Open Label MMF
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Open Label MMF + BMS-986165
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label MMF
n=16 participants at risk
All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks.
Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.
The following suggested target doses of MMF should be reached by the time of randomization:
* 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent
* 3.0 g/day for participants self-described as Black, African American, or of African descent
* 2.0 g/day for all others
|
Open Label MMF + BMS-986165
n=1 participants at risk
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
100.0%
1/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
Other adverse events
| Measure |
Open Label MMF
n=16 participants at risk
All study participants receive Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day for 12 weeks.
Participants who meet the criteria to continue in Part B but do not meet the randomization criteria may continue on open-label MMF with or without corticosteroids.
The following suggested target doses of MMF should be reached by the time of randomization:
* 1.5 to 2.0 g/day for participants self-described as Asian or of Asian descent
* 3.0 g/day for participants self-described as Black, African American, or of African descent
* 2.0 g/day for all others
|
Open Label MMF + BMS-986165
n=1 participants at risk
After 12 weeks of treatment with Mycophenolate Mofetil (MMF) at a dose of 1.5 to 3.0 g/day in Part A, participants meeting randomization criteria for Part B receive BMS-986165 6 mg BID + continued open-label MMF with or without corticosteroids through 52 weeks. Randomized participants may continue to receive blinded study treatment for 52 additional weeks.
|
|---|---|---|
|
Ear and labyrinth disorders
Deafness neurosensory
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Gastrointestinal disorders
Haematochezia
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
General disorders
Pyrexia
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Hepatobiliary disorders
Gallbladder polyp
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Infections and infestations
COVID-19
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
100.0%
1/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Investigations
Blood pressure increased
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
100.0%
1/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
100.0%
1/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Investigations
Weight increased
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
100.0%
1/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
0.00%
0/1 • All-cause mortality was assessed from first dose to study completion (up to approximately 26 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 16 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER